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Completed

NCT Number: NCT02379312

Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams

To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.

On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 20 and 30 kg/m² (inclusive)
  • Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).

Exclusion criteria

  • Dislike, allergy or intolerance to test products
  • Eating disorder (measured by SCOFF questionnaire, > 2 "yes" responses)
  • High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score > 14
  • Reported medical treatment that may affect eating habits/satiety

Treatment and study plan

Very low energy aerated beverage

Dietary Supplement

Normal energy aerated beverage 1

Dietary Supplement

Normal energy aerated beverage 2

Dietary Supplement

Normal energy aerated beverage 3

Dietary Supplement

Primary outcomes

  1. Hunger and satiety questions

    Time frame: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min

    Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)

Secondary outcomes

  1. Electronic Visual Analogue Scale (EVAS) for liking questions

    Time frame: Time point 15 min

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Eurofins Optimed

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2015
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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